Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique

FDA device recall Z-1062-2013 · posted 2013-04-05 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.

Action taken

Synthes sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter requested consignees examine inventory, remove the recalled products from use and return them to Synthes. If you have any questions, contact the firm at 610-719-5450.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

328

Distribution

Nationwide Distribution including the states of AZ, CA, CO, FL, IA, ID, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VT, WA, WI, and WV.

Date initiated

2013-01-11

Date posted

2013-04-05

Date terminated

2015-08-31

Location

West Chester, PA